Department of Radiation Oncology, MD Anderson Cancer Center, Houston, Texas.
Allegheny General Hospital, Department of Radiation Oncology, Pittsburgh, Pennsylvania.
Int J Radiat Oncol Biol Phys. 2020 Aug 1;107(5):897-908. doi: 10.1016/j.ijrobp.2020.04.036. Epub 2020 Apr 29.
Clinical trials are considered the gold standard in evidence-based medicine, yet few patients with cancer ultimately enroll. Here we examine patients screened for thoracic radiation oncology clinical trials to better understand enrollment trends.
A prospective database tracking screening and enrollment for patients referred for thoracic radiation oncology consultation at our institution from 2016 to 2019 was evaluated. Proportional enrollment rates, patient and disease characteristics, self-reported socioeconomic factors, and reasons for ineligibility or nonenrollment across 17 radiation therapy trials were compared.
Enrollment data on 2372 patients were available for analysis. Of these patients, 40.0% (949) were deemed "not eligible" (NE) for any trial or were unwilling to be further screened. Reasons for ineligibility included stage (44%), histology (13%), radiation therapy not indicated (12%), patient decision (7%), and enrollment in a competing medical or surgical oncology trial (5%). The remaining 60.0% (1423) were "potentially eligible" (PE) for one or more trials. Most had non-small cell lung cancer (71%) or esophageal cancer (16%), and there were significantly fewer stage IV PE (29%) versus NE (49%) patients (P < .0001). Of 2372 patients, 281 (11.9%) enrolled. Notable reasons for nonenrollment were inclusion and exclusion criteria (58%), patients declining enrollment (14%), and physician decision (5%). The proportion of white patients was higher in the PE versus NE group (82.5% vs 75.8%; P < .001). Additionally, white race (87.9% vs 81.2%; P = .008), English language preference (96.4% vs 92.9%; P = .032), and non-Hispanic/Latino ethnicity (94.0% vs 90.1%; P = .042) were significantly different in enrolled versus nonenrolled PE patients.
Only 12% of patients screened for radiation therapy trials ultimately enrolled, and more than two-thirds had no trial available or were found ineligible. In addition, 19% of potential eligible patients did not enroll because the patient or physician declined. Future trials may benefit from pragmatic designs with more inclusive enrollment criteria and multidisciplinary engagement of referring providers.
临床试验被认为是循证医学的金标准，但最终只有少数癌症患者入组。本研究旨在通过对接受胸部放射肿瘤学临床试验筛选的患者进行研究，以更好地了解入组趋势。
本研究评估了 2016 年至 2019 年期间在我院进行胸部放射肿瘤学咨询的患者的前瞻性数据库跟踪筛选和入组情况。比较了 17 项放射治疗试验中，患者比例、患者和疾病特征、自我报告的社会经济因素以及因不符合条件或未入组的原因。
共 2372 名患者的入组数据可用于分析。其中 40.0%（949 名）被认为因任何试验或不愿意进一步筛选而“不符合条件”（NE）。不符合条件的原因包括分期（44%）、组织学（13%）、不建议进行放射治疗（12%）、患者决定（7%）以及参加竞争的医学或外科肿瘤学试验（5%）。其余 60.0%（1423 名）为“可能符合条件”（PE），可入组一项或多项试验。大多数患者患有非小细胞肺癌（71%）或食管癌（16%），而 IV 期 PE 患者（29%）明显少于 NE 患者（49%）（P<0.0001）。在 2372 名患者中，281 名（11.9%）入组。未入组的主要原因包括纳入和排除标准（58%）、患者拒绝入组（14%）和医生决定（5%）。与 NE 组相比，PE 组的白人患者比例更高（82.5% vs 75.8%；P<0.001）。此外，白人种族（87.9% vs 81.2%；P=0.008）、英语偏好（96.4% vs 92.9%；P=0.032）和非西班牙裔/拉丁裔（94.0% vs 90.1%；P=0.042）在入组和未入组的 PE 患者中存在显著差异。
仅有 12%的放射治疗试验筛选患者最终入组，超过三分之二的患者没有可用的试验或被认为不符合条件。此外，19%的潜在合格患者因患者或医生拒绝而未入组。未来的试验可能受益于更具包容性的纳入标准和多学科参与的实用设计。
